Growth Promoters: If You Can’t Convince Them, Sue Them

A little less than a year ago, the Food and Drug Administration took a step that, depending on your point of view, was either far too activist or nowhere-near-enough-but-good-try: It proposed, in a draft document, that the agricultural industry voluntarily restrict its use of growth-promoting micro-doses of antibiotics.

It was a significant step. The FDA has been trying to restrict subtherapeutic use of antibiotics in livestock since the 1970s because of the practice’s clear contribution to the development of antibiotic resistance, and had always been defeated. At the same time, it was far from bold: The proposal was made in a draft document that would be made final at some unspecified future date, and that when it became final would have behind it no force of regulation or law. (Here’s my long discussion from last year of the context and history of FDA’s move.)

Clearly, things aren’t moving very fast. So today, a coalition of nonprofit groups attempted to get the issue jump-started: They sued.

The Natural Resources Defense Council (NRDC), Center for Science in the Public Interest (CSPI), Food Animal Concerns Trust (FACT), Union of Concerned Scientists (UCS) and Public Citizen filed a lawsuit in federal court in New York, against the FDA; its Commissioner, Margaret Hamburg, and its director for the Center of Veterinary Medicine, Bernadette Dunham; the Department of Health and Human Services, FDA’s parent agency; and HHS Secretary Kathleen Sibelius.

The suit alleges that the FDA has acted unlawfully, ignoring its own statutory authority, by failing to curb growth-promoting antibiotic dosing despite decades of evidence that it stimulates the emergence of antibiotic resistance, undermining medical treatment and harming human health. It makes these specific claims:

The FDA is empowered by the Food and Drug Act to withdraw its final approval for any drug, even after the drug is approved and marketed, if the drug can be shown to be not-safe in the uses for which it was approved. The suit alleges the FDA concluded in 1977 that subtherapeutic use of both penicillin (approved in 1951) and tetracyclines (approved in 1954) was unsafe, but has never acted.

The FDA is required by its own implementing regulations to respond to citizen petitions that responsibly allege harm from unsafe drugs. The suit alleges that the FDA failed to respond to two citizen petitions that were filed in 1999 and 2005 by members of CSPI, FACT, UCS and Public Citizen. Both petitions asked the agency to lift its approval for growth-promoting use of seven classes of antibiotics that are critical in human medicine, on the grounds that farm micro-doses stimulate the development of antibiotic resistance that then makes the drugs useless in treating human infections.

The suit asks that the FDA respond to the petitions, examine the farm use of those antibiotics, and specifically revoke its approval for growth-promoting use of penicillins and tetracyclines, the issue that it has been not-responding to for 34 years.

(Update to clarify: Antibiotics are administered to livestock via food and water both for growth promotion — making animals gain weight faster — and for prophylaxis — that is, to prevent diseases caused by the confinement conditions in which they are held. Both of those uses are accomplished by subtherapeutic, that is, “smaller than treatment-sized,” dosing. And, important: In both these cases, the drugs are going to animals that are healthy; they are not being used to cure disease in animals that are already sick. No one objects to giving drugs to sick animals to make them better, but that is not what is at issue here.)

The suit makes for fascinating reading, because as part of its argument, it goes through the long history of the FDA’s attempts to address this issue, and the equally long history of Congressional committees quashing the agency when it tried. That persistent failure to get traction may be why the nonprofits decided to press this suit — despite the reintroduction in Congress of the Preservation of Antibiotics for Medical Treatment Act (PAMTA), the lone piece of legislation that would address this issue, and the eventual approval of the FDA guidance in some possibly watered-down form.

“The reason we’re filing suit now is because the antibiotic resistance crisis is reaching alarming proportions,” Avi Kar, NRDC’s health program attorney, told me. “In the face of the growing scientific evidence, FDA continues to focus almost exclusively on voluntary approaches such as those in the guidance currently under development. The coalition lawsuit is designed to get FDA to stop punting the issue and to finally take meaningful action.”

Update: In response to a query from me yesterday, Laura Alvey, deputy director of the Office of Communication in the FDA’s Center for Veterinary Medicine emailed this morning: “[T]he FDA is currently reviewing the comments received and determining next steps. There is no estimated timeframe, but moving forward with strategies for implementing the recommendations outlined in the draft guidance is a priority for the agency. FDA intends to finalize the draft guidance (Guidance #209) in the near future as well as issue additional more detailed guidance on implementing the recommendations in Guidance #209.”